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A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes

NCT06385327 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-03-30

No results posted yet for this study

Summary

This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-5366 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-5366 in Part B in participants seropositive for Herpes Simplex Virus Type 2 (HSV-2) with recurrent genital herpes. Effect of food will also be evaluated in Part A.

Conditions

  • Recurrent Genital Herpes Simplex Type 2

Interventions

DRUG

ABI-5366

Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD)

DRUG

ABI-5366 Placebo

Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD)

Sponsors & Collaborators

  • Assembly Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-30
Primary Completion
2026-02-03
Completion
2026-02-03

Countries

  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06385327 on ClinicalTrials.gov